Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Gevalin: Single capsule of Gevalin once a day for 56 days
Control Intervention1: Placebo: Single capsule of Placebo once a day for 56 days
Sponsors
ZeusHygia LifeSciences Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects diagnosed with functional dyspepsia (Rome IV) within 6 months before screening. 2.Subjects with 4 or more of the 10 symptoms in the Gastrointestinal symptom questionnaire and have a total score of 12 or more.3.Subjects who agrees to participate in this human application test and signs a written consent form before the test begins
Exclusion criteria
Exclusion criteria: 1.Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors, etc.2.Subjects with a history of peptic ulcer or reflux esophagitis within 6 months of Visit 1.3.Subjects with a history of gastrointestinal surgery (excluding appendectomy and hemorrhoidectomy).4.Subjects with a history of malignant tumor of the digestive system.5.Subjects who have within 2 weeks of Visit 1, have taken H2 receptor blockers, anticholinergics (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosa protectors, other drugs for the treatment of gastritis, and health functional foods related to gastrointestinal health.6.Subjects who must continuously take drugs that can cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin, during the human application test period (however, low dose aspirin (100 mg per day or less) is allowed for the purpose of preventing cardiovascular disease).7.Subjects with score of 5 or more according to the alcohol use questionnaire.8.Subjects with uncontrolled high blood pressure (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher).9.Subjects with uncontrolled diabetes (HbA1C grater than 7.0%).10.Subjects whose creatine level is more than twice the normal upper limit of the testing institution.11.Subjects whose AST or ALT is more than 3 times the upper limit of normal.12.Subjects who are sensitive or allergic to the food ingredients for this human application test.13.Subjects refusing to stop eating foods and functional foods.14.Subjects who are pregnant, lactating, or planning to become pregnant within 3 months.15.Subjects who have participated in other interventional clinical trials (including human trials) within 3 months of visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial.16.Subjects judged by the tester to be inappropriate for this human application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of the investigational product (IP) in improving gastrointestinal symptomsTimepoint: Day 0, Day 7, Day 28 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the lifestyle and sleep quality using respective surveys in symptomatic subjectsTimepoint: Baseline, Day 7, Day 28 and Day 56;To assess the efficacy on biomarkersTimepoint: Day 0 and Day 56;To study the safety and tolerability of the study supplementTimepoint: Day 0, Day 7, Day 28 and Day 56 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed